BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5209155 · Received November 7, 2015

    Report

    Report Number
    2939301-2015-47768
    Event Type
    Malfunction
    Date Received
    November 7, 2015
    Report Date
    October 28, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ONE TOUCH). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿250, 207 AND 285 MG/DL¿ WITH THE SUBJECT METER. THE REPORTER WAS UNABLE TO GIVE RESULTS FOR THE OTHER DEVICE. THE TIME BETWEEN TESTS IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULTS MAY NOT HAVE MET LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739551 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3786722

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR